Manufacturing Engineer I

Integra Lifesciences Holdings Corporation

Full-time - Entry Level

1,001-5,000 employees

Management of Companies and Enterprises

About the position

The Manufacturing Engineer I will play a key role in supporting manufacturing operations, process scale-up, and manufacturing improvement activities. This position is crucial for overseeing projects that evaluate, analyze, and improve existing processes, as well as supporting the development of new manufacturing processes. The engineer will implement statistical process controls, analyze and trend existing process parameters, improve manufacturing yields, reduce scrap, and error-proof manufacturing processes. This role requires a proactive approach to problem-solving and a commitment to maintaining high standards of quality and compliance with regulatory requirements. In this position, the Manufacturing Engineer I will engage in process engineering and project management to support process scale-up and current manufacturing operations. Projects will vary in complexity and may pose significant risks to product and processes if not designed and implemented correctly. The engineer will be responsible for completing projects aimed at evaluating, analyzing, and improving existing processes, troubleshooting manufacturing processes, and ensuring that all documentation, drawings, and specifications comply with Integra's procedures and statutory requirements, including US FDA and ISO standards. The role also involves initiating, developing, and implementing IQ/OQ/PQ validations for equipment and processes to meet the demands of new product introductions and current manufacturing operations. The engineer will coordinate efforts required by the project team, which includes developing manufacturing process requirements, specifications, validations, Engineering Change Orders (ECO), and Engineering Drawings. Additionally, the engineer will support projects to implement statistical process control, analyze and trend existing process parameters, and improve manufacturing yields while reducing scrap and error-proofing processes. The Manufacturing Engineer I will conduct timely technical investigations and provide practical manufacturing solutions under appropriate regulatory guidelines for Medical Device Manufacture. This includes conducting Non-Conformance Investigations and assisting or leading in the prompt implementation of Non-Conformance resolution and Corrective and Preventive Action(s) (CAPA support). Collaboration with technical teams across various departments such as Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs is essential for the success of identified projects and products. The engineer will also provide daily analytical and technical support to meet manufacturing objectives and apply their experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing.

Responsibilities

• Process engineering and project management to support process scale-up and current manufacturing operations.
• Complete projects aimed to evaluate, analyze, and improve existing processes.
• Support the development of new manufacturing processes and troubleshoot manufacturing processes.
• Ensure compliance with documentation, drawings, and specifications according to Integra's procedures and statutory requirements.
• Initiate, develop, and implement IQ/OQ/PQ validations for equipment and processes.
• Coordinate specific efforts required by the project team, including development of manufacturing process requirements and specifications.
• Support projects to implement statistical process control and analyze existing process parameters.
• Perform timely technical investigations and provide practical manufacturing solutions under regulatory guidelines.
• Conduct Non-Conformance Investigations and assist in the implementation of Non-Conformance resolution and CAPA support.
• Collaborate in technical teams for identified projects and products across various departments.
• Implement problem-solving skills to identify potential issues and develop mitigation plans.
• Provide plant input in manufacturing process development, including process design requirements and risk analysis.
• Provide daily analytical and technical support to meet manufacturing objectives.
• Lead the selection and/or design of equipment for prototype and full-scale manufacturing.

Requirements

• Bachelor's degree in Engineering (Mechanical, Pharmaceutical, Chemical, Biomedical) or equivalent experience.
• 0-2 years of experience in manufacturing engineering within the medical device industry.
• Experience with Quality System Regulation (QSR), Design Control, and Process Validation guidelines.
• Knowledge of Engineering Change Controls, ISO, and Regulatory guidelines is required.
• Experience with biomaterials, cleanrooms, and Lyophilization is a plus.
• Experience with Statistical Process Control tools (SPC, Minitab, other software).
• General chemistry, processing, and material expertise.
• Considerable knowledge of engineering principles and practices as applied to various projects.
• Ability to prepare complex technical reports, project summaries, and correspondence.
• Exceptional practical problem-solving skills and excellent organizational and communication skills.

Nice-to-haves

• Experience in a cleanroom environment.
• Familiarity with Lyophilization processes.